Predictive Factors Study (TAPAS)
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ClinicalTrials.gov Identifier: NCT02020499 |
Recruitment Status :
Terminated
(Poor enrolment)
First Posted : December 25, 2013
Last Update Posted : January 14, 2019
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Condition or disease | Intervention/treatment |
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Acromegaly | Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg. |
Study Type : | Observational |
Actual Enrollment : | 5 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Non-interventional, Observational, Long Term Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel (ATG) Treatment in Patients With Acromegaly. |
Study Start Date : | August 2014 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |

Group/Cohort | Intervention/treatment |
---|---|
Acromegalic patients
Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)
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Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
Patients receiving treatment as prescribed by the investigator and according to current treatment recommendations and routine clinical practice, and in line with local regulations. |
- Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline [ Time Frame: Baseline and 4 weeks ]
- Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline [ Time Frame: Baseline, 1 year and 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Diagnosis of Acromegaly.
- Males and females aged 18 years and older.
- Signed informed consent (patient must give consent to the collection of retrospective data).
- Patients who have had surgery may enter the study 3 months post-surgery and evaluated for the duration of the study.
- With the intention to be treated with ATG (decision to prescribe ATG made prior to inclusion into the study) or already being treated with ATG.
- If already being treated with ATG:
Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data, disease history including previous treatments, GH, IGF-1 levels at baseline and under treatment as applicable).
- Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other somatostatin analogues) for the treatment or symptom control of acromegaly.
Exclusion Criteria:
- The subject has had radiotherapy in the last 5 years.
- The subject has had surgery in the last 3 months.
- The subject has already been included in this study.
- Participation in an interventional trial, or receiving experimental drug.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020499
Australia, New South Wales | |
St Vincent's Hospital | |
Darlinghurst, New South Wales, Australia, 2010 | |
Royal North Shore Hospital | |
St Leonards, New South Wales, Australia, 2065 | |
Australia, Queensland | |
Royal Brisbane & Women's Hospital | |
Herston, Queensland, Australia, 4006 | |
Princess Alexandra Hospital | |
Woolloongabba, Queensland, Australia, 4102 | |
Australia, Victoria | |
St Vincent's Hospital | |
Fitzroy, Victoria, Australia, 3065 | |
The Austin Hospital | |
Heidelberg, Victoria, Australia, 3084 |
Study Director: | Ipsen Medical Director | Ipsen |
Responsible Party: | Ipsen |
ClinicalTrials.gov Identifier: | NCT02020499 |
Other Study ID Numbers: |
A-9B-52030-265 |
First Posted: | December 25, 2013 Key Record Dates |
Last Update Posted: | January 14, 2019 |
Last Verified: | January 2019 |
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Lanreotide Angiopeptin Antineoplastic Agents |